Micra AV MC1AVR1 - Intracardiac pacemaker

Intended purpose

Transcatheter pacing systems are sterile, single-use only, active implantable medical devices that are implanted in patients by health care professionals trained in cardiology. Transcatheter pacing systems are intended to improve cardiac output, prevent symptoms of and protect against arrhythmias related to cardiac impulse formation or conduction disorders by providing pacing therapy to the heart. Micra AV Model MC1AVR1 is indicated for VDD pacing in patients when a dual chamber transvenous pacing system is considered a poor option or not deemed necessary for effective therapy, and when a right ventricular transcatheter pacing system promoting AV synchrony at rest is acceptable. Conditions when a patient is considered a poor candidate for transvenous pacing may include, but are not limited to, tortuous anatomy, a need to preserve venous access, or increased risk of infection. The device provides AV synchrony at rest and rate responsive (VVIR) pacing during periods of high patient activity. Device-mediated AV synchrony can vary depending on patient condition and activity levels, and it can be limited at high sinus rates. During periods of intermittent AV synchrony, the device will provide ventricular pacing support with an increased potential for pacing rate variability. Micra AV Model MC1AVR1 is indicated for use in patients who have experienced one of the following: • Paroxysmal or permanent high-grade AV block in the absence of AF • Paroxysmal or permanent high-grade AV block in the presence of paroxysmal AF • Paroxysmal or permanent high-grade AV block in the presence of persistent AF when attempts at restoring sinus rhythm are still planned The device is designed to be used only in the right ventricle.

Functional description

MR Conditional dual chamber, transcatheter pacing system with SureScan technology is a programmable cardiac device that monitors and regulates the patient’s heart rate by providing rate-responsive bradycardia pacing to the right ventricle and AV synchrony based on the mechanical sensing of atrial activity. The device senses both the electrical activity and the mechanical activity of the patient’s heart using sensing and pacing electrodes and an accelerometer enclosed in a titanium capsule.